UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041941 |
|---|---|
| Receipt number | R000044520 |
| Scientific Title | Distribution of heart rate variability in the upper grades of elementary school where school can be attended |
| Date of disclosure of the study information | 2020/12/20 |
| Last modified on | 2020/09/29 22:27:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Distribution of heart rate variability in the upper grades of elementary school who can attend school
Acronym
NHRV test
Scientific Title
Distribution of heart rate variability in the upper grades of elementary school where school can be attended
Scientific Title:Acronym
NHRV test
Region
| Japan |
Condition
Condition
Elementary school seniors who can attend school
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In children unable to attend school, changes in heart rate variability (HRV) over time can be observed . There are no reports of normal HRV values in children recorded using the types of HRV-measuring instruments currently available in Japan. In order to identify the abnormalities present in the HRV of children who refuse to attend school, data for normal values were gathered first.
Basic objectives2
Others
Basic objectives -Others
It is already known that measured HRV values can change due to age, posture, and the presence or absence of heart failure, diabetes mellitus, and ischemic heart disease. In addition to the above-mentioned conditions, mood disorders are also reported to cause changes in HRV. Refusal to attend school in children is often associated with mood disorders. To identify HRV abnormalities in children who refuse to attend school, the distribution of HRV in children in the upper grades of elementary school who attend school was examined first.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
HRV is measured for elementary school seniors, CVRR obtained from SDNN and Mean from the time series analysis, VLF, LF, HF, Total Power, etc. from the frequency analysis by AR-Power Spectrum (Non-Detrend), naturally converted numerical values are added, and the average value and standard deviation are obtained.
Key secondary outcomes
Using the results of frequency analysis, we confirm the conditions for obtaining a normal distribution for raw data and natural random conversion values.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elementary school children who can attend school and take regular classes
Key exclusion criteria
Children who are unable to take regular classes and are only in the infirmary
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ikeya |
Organization
Ikeya Clinic
Division name
Dean
Zip code
436-0088
Address
2-10-14 Katsuragaoka,Kakegawa City,Shizuoka Pref.,Japan,436-0088
TEL
0537-22-0433
ikeya-25@fancy.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ikeya |
Organization
Ikeya Clinic
Division name
Dean
Zip code
436-0088
Address
2-10-14 Katsuragaoka,Kakegawa City,Shizuoka Pref.,Japan,436-0088
TEL
0537-22-0433
Homepage URL
ikeya-25@fancy.ocn.ne.jp
Sponsor or person
Institute
Ikeya Clinic
Institute
Department
Personal name
Funding Source
Organization
Ikeya Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chutoen General Medical Center
Address
1-1 Shobugaike,Kakegawa City,Shizuoka Pref.,Japan,436-3555
Tel
-0537-21-0555
rinshokenkyu@chutoen-hp.shizuoka.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
池谷医院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
Results
HRV measurements were performed in 28 children with a mean age of 11 years at school using a portable electrocardiographic monitor. The normality of the results and of the natural logarithms of the numerical values was examined. A normal distribution was only confirmed for CVRR and for HF subject to natural logarithm transformation.
Results date posted
| 2020 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
HRV was measured in patients with dyslipidia at an average age of 60 years.
The mean values (and standard deviations) for HRV measured for 5 minutes subjected to natural logarithm transformation were as follows: the coefficient of variance of RR intervals (CVRR) was 1.13(0.35); the total power was 6.07 (0.90); the very low frequency (VLF) band was 5.66 (1.00); the low frequency (LF) band was 4.16 (0.90); and the high frequency (HF) band was 3.99 (0.90). All test items showed normality distribution.
Management information
Registered date
| 2020 | Year | 09 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044520
